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Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006185
First Posted: August 23, 2000
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose

With the advent of highly active anti-retroviral therapy(HAART), patients with HIV disease are developing a series of metabolic abnormalities including peripheral fat wasting, increase in truncal fat, high serum triglyceride levels, insulin(a hormone that controls blood sugar) resistance with an increased incidence of Type 2 Diabetes Mellitus and elevated blood pressure. The premise of this study is that abnormalities in the ability of fat and muscle tissue to respond to the hormone insulin may be the cause of the diabetes mellitus, high serum triglyceride levels and abnormal fat distribution. The purpose of the study is to assess how insulin resistant patients with HIV disease are and if their fat and muscle tissue are responding abnormally to insulin. This is done by administering insulin and taking small tissue samples of fat and muscle from the upper thigh and assessing how good insulin acts in these tissues.

Patients with HIV disease will be admitted into the study after undergoing a screening medical history and examination. Once patients qualify, they will have their insulin resistance measured as well as the response of their fat and muscle to insulin; blood levels of glucose (sugar), cholesterol and triglycerides will be measured; body fat will be assessed using radiological tests; a detailed medical history will be obtained to assess risk factors for developing this syndrome.

Patients who are found to be insulin resistant will be offered a trial of an insulin sensitizing agent, called Avandia, for 6-12 weeks. It is hoped that the Avandia will restore the body's ability to respond normally to insulin (as it does in patients with Diabetes) and perhaps improve the fat abnormalities as well. All the same measures will be performed at the end of the course of Avandia as were done at baseline.

Patients who are not insulin resistant will be asked to come back yearly to assess whether they develop insulin resistance over time. This study will continue to recruit patients over the next 3 years.


Condition Intervention Phase
HIV Infections Lipodystrophy Insulin Resistance Drug: Avandia administration for 6-12 weeks Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cellular Mechanisms for Metabolic Dysfunction in HIV

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: September 1999
Estimated Study Completion Date: August 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • Diagnosis of HIV or AIDS

Exclusion Criteria:

  • Positive pregnancy test
  • Diagnosis of cancer
  • Acute illness (patients can be enrolled once stable)
  • Hemoglobin less than 7.0 g/dl or acute heart problems
  • Renal function greater than creatinine 1.5 mg/dl
  • Liver dysfunction 3 times normal
  • Use of medications like glucocorticoids and birth control pills
  • Untreated hypertension
  • Diabetes mellitus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006185


Locations
United States, New York
University Hospital at Stony Brook New York
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Study Director: Dr.Marie Gelato SUNY at Stony Brook
  More Information

ClinicalTrials.gov Identifier: NCT00006185     History of Changes
Other Study ID Numbers: hivtzd (completed)
DK49316-06
First Submitted: August 22, 2000
First Posted: August 23, 2000
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
peripheral fat wasting
truncal adiposity
fat biopsy
muscle biopsy
intravenous lines
blood draws
insulin administration
sugar water
screening

Additional relevant MeSH terms:
HIV Infections
Insulin Resistance
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders